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Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

NCT04519294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-02-27

Study results available
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Summary

The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.

Conditions

  • Kidney Stone
  • Renal Stone
  • Urolithiasis

Interventions

DEVICE

SURE

The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.

DEVICE

Standard Ureteroscopy (Basketing)

This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.

Sponsors & Collaborators

  • Calyxo, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2023-01-30
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519294 on ClinicalTrials.gov